HIV Risk Perception, Willingness to Use PrEP, and PrEP Uptake Among Young Men who have Sex with Men in Washington, DC.

Low HIV risk perception is a barrier to PrEP uptake, but few studies have examined risk perception and PrEP uptake among young men who have sex with men (YMSM). We performed a secondary analysis of data collected in 2016 from YMSM ages 16-25 in the Washington, DC metropolitan area who participated in a cross-sectional online survey that aimed to identify strategies for engaging YMSM in PrEP services. Of 188 participants, 115 (61%) were considered eligible for PrEP. Among PrEP-eligible participants who had never used PrEP, 53%, 71%, and 100% with low, moderate, and high risk perception, respectively, were willing to use PrEP (Fisher's exact test p = 0.01). Odds of PrEP willingness were greater among those with moderate/high versus low risk perception (adjusted odds ratio [OR] = 5.62, 95% CI = 1.73-18.34). HIV risk perception was not significantly associated with self-reported PrEP use. These findings suggest the importance of risk perception as a correlate of willingness to use PrEP, which is a key step in existing frameworks of PrEP uptake.

Acceptability and Effectiveness of a One-Hour Healthcare Provider Intervention Integrating HIV Pre-Exposure Prophylaxis and Cultural Competence Training.

Enhanced provider training could improve PrEP access and equity. We conducted a pilot randomized controlled trial comparing (a) a one-hour, group-based provider intervention integrating PrEP and Cultural Competence (PCC) training with (b) a standard HIV continuing medical education session (n = 56). PCC participants favorably rated the intervention and reported increased PrEP knowledge. The PCC intervention increased their confidence performing PrEP-related clinical activities and intention to prescribe PrEP. The percentage of participants discussing PrEP with patients increased marginally in both study conditions. The percentage of participants who prescribed PrEP and self-rated cultural competence did not change in either study condition.

RESUMEN: Una mejor capacitación de los proveedores podría mejorar el acceso y la equidad de la PrEP. Realizamos un ensayo controlado aleatorizado piloto que comparó (a) una intervención grupal de proveedores de una hora que integraba la capacitación en PrEP y competencia cultural (PCC) con (b) una sesión estándar de educación médica continua sobre el VIH (n = 56). Los participantes de PCC calificaron favorablemente la intervención e informaron un mayor conocimiento de la PrEP. La intervención de PCC aumentó su confianza en la realización de actividades clínicas relacionadas con la PrEP y su intención de prescribir la PrEP. El porcentaje de participantes que discutieron la PrEP con los pacientes aumentó marginalmente en ambas condiciones del estudio. El porcentaje de participantes que prescribieron la PrEP y la competencia cultural autoevaluada no cambió en ninguna de las condiciones del estudio.

'There are people like me who will see that, and it will just wash over them': Black sexual minority men's perspectives on messaging in PrEP visual advertisements.

The high incidence of HIV among US Black sexual minority men is a public health crisis that pre-exposure prophylaxis (PrEP) for HIV can help address. Public health campaigns, which often include pictures of Black sexual minority men alongside PrEP-related messaging, have been developed to encourage PrEP awareness and uptake. However, the acceptability of the messaging within these campaigns among Black sexual minority men is unclear. We conducted four focus groups with 18 HIV-negative Black sexual minority men in Washington, DC to explore their perspectives regarding promotional messaging (textual elements) in PrEP visual advertisements, including their reactions to three large-scale public health campaigns. Primary themes included: (1) the need for additional information about PrEP, (2) preference for slogan simplicity, (3) the desire to normalise PrEP use, and (4) mixed views on the inclusion of condoms. Results indicated that the messaging in current PrEP visual advertisements may not sufficiently address Black sexual minority men's questions about PrEP. Providing basic PrEP information and methods to access more information; using simple, unambiguous language; presenting PrEP use in a destigmatising, normalising fashion; and conveying the relevance of condoms if included in the advertisement could help increase the acceptability of future PrEP advertising among Black sexual minority men.

Optimizing Provider Preexposure Prophylaxis (PrEP) Training: A Cross-Sectional Analysis of Recommendations from Providers Across the PrEP Implementation Cascade.

Expanding PrEP access necessitates training that supports healthcare providers' progression along the PrEP implementation cascade, moving from PrEP awareness to prescription. We surveyed 359 USA providers about PrEP training content and format recommendations. We examined the association between cascade location and training recommendations. Most providers were aware of PrEP (100%), willing to prescribe PrEP (97.2%), had discussed PrEP with patients (92.2%), and had prescribed PrEP (79.9%). Latent class regression analysis revealed that cascade location was associated with training recommendations. Although all providers recommended PrEP-specific content (e.g., patient eligibility), providers who were located further along the cascade also recommended more comprehensive content, including sexual history-taking and sexual and gender minority competence training. Providers further along the cascade were also more likely to recommend interactive training formats (e.g., role-playing). These insights from providers furthest along the cascade indicate the importance of including comprehensive content and interactive formats in future PrEP training initiatives.

An Experimental Study of the Effects of Patient Race, Sexual Orientation, and Injection Drug Use on Providers' PrEP-Related Clinical Judgments.

Social biases may influence providers' judgments related to pre-exposure prophylaxis (PrEP) and patients' consequent PrEP access. US primary and HIV care providers (n = 370) completed an experimental survey. Each provider reviewed one fictitious medical record of a patient seeking PrEP. Records varied by patient race (Black or White) and risk behavior (man who has sex with men [MSM], has sex with women [MSW], or injects drugs [MID]). Providers reported clinical judgments and completed measures of prejudice. Minimal evidence of racially biased judgments emerged. Providers expressing low-to-moderate sexual prejudice judged the MSM as more likely than the MSW to adhere to PrEP, which was associated with greater PrEP prescribing intention; sexual prejudice was negatively associated with anticipated MSM adherence. Providers judged the MID to be at higher risk, less likely to adhere, less safety-conscious, and less responsible than both the MSM and MSW; adverse adherence and responsibility judgments were associated with lower prescribing intention.

RESUMEN: Los sesgos sociales pueden influir sobre los juicios de proveedores de salud con respecto a la profilaxis pre-exposición (PrEP) y el consecuente acceso de los pacientes a PrEP. Proveedores de cuidados primarios y de VIH en los Estados Unidos (n = 370) respondieron una encuesta experimental. Cada proveedor leyó una historia médica de un paciente ficticio interesado en obtener PrEP. Las historias médicas variaron la raza (Negro o Blanco) y conducta de riesgo (hombre que tiene sexo con hombres [HSH], hombre que tiene sexo con mujeres [HSM], u hombre  usuario de drogas inyectables [HDI]) del paciente. Los proveedores reportaron juicios clínicos y completaron medidas sobre prejuicio. La evidencia sobre sesgos raciales en los juicios clínicos fue mínima. Los proveedores que expresaron prejuicio sexual bajo a moderado, juzgaron que el paciente HSH tendría mayor adherencia a PrEP que el paciente HSM, lo cual se asoció con mayor intención de prescribir PrEP; el prejuicio sexual se asoció negativamente con la adherencia anticipada en HSH. El paciente HDI fue percibido como en mayor riesgo, con menor adherencia, menos preocupado por la seguridad, y menos responsable que los HSH y HSM; los juicios sobre baja adherencia y responsabilidad estuvieron asociados con menor intención de prescribir PrEP.

Sexual behavior and medication adherence in men who have sex with men participating in a pre-exposure prophylaxis study of combinations of Maraviroc, Tenofovir Disoproxil Fumarate and/or Emtricitabine (HPTN 069/ACTG 5305).

HPTN 069/ACTG 5305 was designed to evaluate potential new PrEP regimens that included maraviroc, tenofovir disoproxil fumarate, and/or emtricitabine. The current analyses assessed antiretroviral (ARV) plasma concentrations in relation to sexual behavior in 224 cisgender men who have sex with men and 2 transgender women at risk for HIV. Poisson generalized estimating equations (GEE) regression were used to test for associations between self-reported sexual behavior, sociodemographic, behavioral variables, and study drug levels The median (IQR) age was 30 [25, 37] years old; 48.2% had completed college; 27.4% were Black and 21.7% Latino. At weeks 24 and 48, one third of participants reported condomless anal sex (CAS) in the prior month with more than one partner. CAS was associated with daily ARV drug use (χ2 = 12.64, p = 0.002). Older individuals and those with greater education were more likely to ingest ARV drugs daily (χ2 = 9.36, p = 0.009 and χ2 = 8.63, p = 0.013, respectively), while neither race nor ethnicity was associated with daily ARV drug use. Participants who reported recent condomless anal sex and/or advanced education had higher rates of daily ARV drug use. These data support the need for ongoing adherence counseling in clinical trials of new PrEP modalities.

Freedom as Prevention: Mechanisms of Autonomy Support for Promoting HIV Pre-Exposure Prophylaxis Use and Condom Use among Black MSM in 3 US Cities-HPTN 073.

Healthcare providers who use controlling or coercive strategies may compel short-term enactment of HIV and sexually transmitted infection prevention behaviors but may inadvertently undermine their client's motivation to maintain those behaviors in the absence of external pressure. Autonomous motivation refers to the self-emanating and self-determined drive for engaging in health behaviors. It is associated with long-term maintenance of health behaviors. We used structural equation modeling to investigate whether autonomy support was associated with increased odds of therapeutic serum levels of pre-exposure prophylaxis, through a pathway that satisfies basic psychological needs for autonomous self-regulation and competence regarding pre-exposure prophylaxis use. We also investigated whether autonomy support was associated with decreased odds of condomless anal intercourse via the same psychological needs-satisfaction pathway of autonomous self-regulation and competence regarding condom use. We tested these two theorized pathways using secondary data from a longitudinal sample of Black men who have sex with men from across three cities in the US (N = 226). Data from the sample fit the theorized models regarding the pathways by which autonomy support leads to the presence of therapeutic PrEP levels in serum (χ2 = 0.56; RMSEA = 0.04; CFI = .99, TLI = 0.98) and how it also leads to decreased odds of condomless anal intercourse (χ2 = 0.58; RMSEA = 0.03; CFI = 0.99; TLI = 0.98). These findings provide scientific evidence for the utility of self-determination theory as a model to guide intervention approaches to optimize the implementation and impact of PrEP for Black men who have sex with men.

"Let's Be a Person to Person and Have a Genuine Conversation": Comparing Perspectives on PrEP and Sexual Health Communication Between Black Sexual Minority Men and Healthcare Providers.

Patient-provider communication is a key factor affecting HIV pre-exposure prophylaxis (PrEP) awareness and access among Black sexual minority men (SMM). Optimizing patient-provider communication requires a deeper understanding of communication dynamics. In this study, we investigated the perspectives of both HIV-negative/status-unknown Black SMM and practicing community healthcare providers regarding patient-provider communication about PrEP and sexual health. We conducted eleven semi-structured qualitative focus groups (six with Black SMM; five with providers) in the Northeastern USA and thematically analyzed transcripts. A total of 36 Black SMM and 27 providers participated in the focus groups. Our analysis revealed points of alignment and divergence in the two groups' perspectives related to patient-provider communication. Points of alignment included: (1) the importance ascribed to maximizing patients' comfort and (2) belief in patients' right to non-discriminatory healthcare. Points of divergence included: (1) Black SMM's preference for sexual privacy versus providers' preference that patients share sexual information, (2) Black SMM's perception that providers have an ethical responsibility to initiate conversations about PrEP with patients versus providers' perception of such conversations as being optional, and (3) Black SMM's preference for personalized sexual health conversations versus providers' preference for standardized conversations. Findings underscore a need for providers to offer more patient-centered sexual healthcare to Black SMM, which should entail routinely presenting all prevention options available-including PrEP-and inviting open dialogue about sex, while also respecting patients' preferences for privacy about their sexuality. This approach could increase PrEP access and improve equity in the US healthcare system.

HPV knowledge, screening barriers and facilitators, and sources of health information among women living with HIV: perspectives from the DC community during the COVID-19 pandemic.

BACKGROUND: High-risk human papillomavirus (HPV) causes 99% of cervical cancer cases. Despite available prevention methods through the HPV vaccine and two screening modalities, women continue to die from cervical cancer worldwide. Cervical cancer is preventable, yet affects a great number of women living with HIV (WLH). Low screening rates among WLH further exacerbate their already high risk of developing cervical cancer due to immunosuppression. This study explores WLH's current cervical cancer knowledge, screening barriers and facilitators, and sources of health information. METHODS: Focus group discussions were conducted with 39 WLH aged 21 years old or older, who resided in the Washington-Baltimore Metropolitan Area. Emergent themes were classified and organized into overarching domains and assembled with representative quotations. RESULTS: The women had limited knowledge of HPV and the cervical cancer screening guidelines for WLH. Coronavirus 2019 (COVID-19) pandemic has amplified screening barriers due to decreased accessibility to usual medical appointment and cervical cancer screenings. Screening facilitators included knowing someone diagnosed with cervical cancer and provider recommendations. WLH indicated that they obtained health information through in-person education (providers, peer groups) and written literature. Due to the pandemic, they also had to increasingly rely on remote and technology-based communication channels such as the internet, social media, television, radio, email, and short message service (SMS) text messaging. CONCLUSIONS: Future health interventions need to explore the possibility of sharing messages and increasing cervical cancer and HPV knowledge of WLH through the use of SMS and other technology-based channels.

Risk compensation in HIV PrEP adherence among Black men who have sex with men in HPTN 073 study.

While HIV infections among men who have sex men (MSM) have started to decline in the United States, Black MSM continue to experience disproportionate rates of HIV infection. The purpose of this secondary analysis is to examine risk perception and its influence on PrEP adherence among Black MSM from HPTN 073. Risk perception was measured using the adapted Perceived Vulnerability to HIV Scale. The associations between risk perception and PrEP adherence were tested using generalized estimation equation model for time-variant repeated measures. Risk perception was not significantly associated with PrEP adherence. These findings suggest an there was no risk compensation among PrEP users, and inconsistency in perceived risk for HIV. Future studies should investigate the rationale for long term adherence to PrEP among Black MSM.

Sexual Risk Profiles Among Black Sexual Minority Men: Implications for Targeted PrEP Messaging.

Black gay, bisexual, and other Black sexual minority men (BSMM) continue to experience some of the largest sexual health disparities in the U.S. Engaging BSMM in PrEP is crucial to improving sexual health outcomes and reducing disparities. However, knowledge of the profiles of sexual risk and PrEP initiation among this group is limited. This study used latent class analysis to identify HIV risk and PrEP initiation patterns among BSMM in the HPTN 073 Study (n = 226). Guided by current Centers for Disease Control screening guidelines, latent class indicators included relationship status, condom use, number of sexual partners, substance use, sexually transmitted infection (STI) history, and partner HIV status. Age and PrEP initiation were used in a multinomial regression to identify correlates of class membership. Three latent classes were identified: Single, Condomless Partners, Single, Multiple Partners, and Serodiscordant Partners. Single, Condomless Partners had the highest conditional probabilities of having greater than three male partners, substance use before sex, and receiving an STI diagnosis. Serodiscordant Partners had a 100% conditional probability of condomless sex and having a male partner living with HIV. BSMM who initiated PrEP were less likely to be classified as Single, Condomless Partners than Serodiscordant Partners (AOR = 0.07, 95% CI = 0.02, 0.66). Findings support the need for culturally relevant tailored and targeted messaging for BSMM with multiple sexual risk indicators.

Cabotegravir Is Not Associated With Weight Gain in Human Immunodeficiency Virus-uninfected Individuals in HPTN 077.

Studies in human immunodeficiency virus (HIV)-infected individuals suggest excess weight gain with integrase inhibitor-based antiretroviral therapy. The HIV Prevention Trials Network Study 077 evaluated changes in weight and fasting metabolic parameters in HIV-uninfected individuals randomized to cabotegravir or a placebo. No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.

Development and Validation of the Personalized Sexual Health Promotion (SexPro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United States.

Accurate HIV risk assessment among men who have sex with men (MSM) is important to help providers assess risk, and target HIV prevention interventions. We sought to develop an evidence-based HIV risk assessment tool for US MSM that is inclusive of Black MSM. Data from four large longitudinal cohorts of MSM were used to develop (EXPLORE), and validate (VAX004, HPTN061, and HVTN505). These data included visits in which participants self-reported HIV risk behavior and underwent HIV testing. We developed a pooled logistic model for incident HIV infection based on self-reported risk behaviors during the 6 months before each study visit. A total of 4069 MSM were used for the development cohort, and 8047 MSM in the three validation cohorts through 2013. The final model includes age (< 35, ≥ 35); Black race and Latino ethnicity; numbers of HIV-negative anal sex partners; number of insertive or receptive anal intercourse episodes; having 1 HIV-negative partner only; self-reported substance use; and bacterial sexually transmitted infection diagnosis. The model showed good discrimination in internal validation (C-statistic = 79.5). The external validation cohorts also showed good discrimination, with C-statistics of 73.1, 71.0, 71.9 in VAX004, HPTN061, and HVTN505 respectively, and acceptable calibration. We developed and validated an HIV risk assessment tool for MSM, which showed good predictive ability, including among the largest cohort of HIV-uninfected Black MSM in the US. This tool is available online (mysexpro.org) and can be used by providers to support targeting of HIV prevention interventions such as pre-exposure prophylaxis for MSM.

Changes in Sexual and Gender Identity and Their Associations with Internalized Homophobia Among Black Men Who Have Sex with Men in the HPTN 061 BROTHERS Cohort.

Sexual and gender identity have frequently been assessed in public health research as static states. However, a substantial and growing body of evidence indicates that both identities may have greater potential for change over time than once supposed. Despite this evidence, research into adult identity change remains relatively limited. Using longitudinal data from 1553 Black men who have sex with men (BMSM) aged 18-68 years and recruited from study locations in six major cities across the country, we examined changes in sexual and gender identities over a period of 12 months. The results showed that sexual and gender identity did indeed change among adult BMSM. Additionally, we explored internalized homophobia (IH) as a potential driver of identity change and found that IH significantly impacts the degree and direction of change, with individuals who reported higher baseline IH more likely to demonstrate a shift toward a heterosexual/straight identity at 6 and 12 months. The results are discussed in light of what is known and unknown regarding identity change, and potential avenues for future research are explored.

Development of a telehealth intervention to promote care-seeking among transgender women of color in Washington, DC.

BACKGROUND: Transgender women of color (TWC) are an underserved population who often experience high rates of HIV and barriers to care including stigma, violence, and trauma. Few health information technology interventions are tailored to serve TWC. The purpose of this study was to inform the development of a TWC-specific telehealth intervention to increase access to care. METHODS: Formative qualitative semi-structured interviews and focus groups were conducted to develop a customized telehealth intervention for TWC. Participants were TWC ≥ 18 years living in the Washington, DC metropolitan area, with at least one structural barrier to care and clinicians ≥18 years who provide care to TWC. Transcripts were analyzed using thematic coding and content analysis; barriers for TWC were categorized into Individual, Organizational, and Environmental levels. Several day-long meetings with TWC and stakeholders were convened to develop the intervention. RESULTS: Saturation of theme on barriers to care was reached with 22 interviews. Identified barriers to service receipt included survival, instability, temporal discounting, and prioritizing hormone therapy over care, incongruence between providers and patients, pessimism, and lack of cultural competency. Each was intentionally addressed with the telehealth intervention. CONCLUSIONS: Data informed the development of an innovative and customized telehealth intervention for TWC. Through the integration of technology and peer consultant outreach, we developed a novel approach that can address population-specific challenges to care. Further development of this model may be able to improve health outcomes among TWC.

Incidence and Correlates of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Participating in the HIV Prevention Trials Network 073 Preexposure Prophylaxis Study.

BACKGROUND: The HIV Prevention Trials Network (HPTN) Study 073 (HPTN 073) assessed the feasibility, acceptability, and safety of preexposure prophylaxis (PrEP) for black men who have sex with men (BMSM). The purpose of this analysis was to characterize the relationship between PrEP uptake and use and incident sexually transmitted infections (STIs) among participants enrolled in HPTN 073. METHODS: A total of 226 human immunodeficiency virus (HIV)-uninfected BMSM were enrolled in 3 US cities; all participants received client-centered care coordination (C4) and were offered daily oral PrEP. Participants were followed for 12 months with STI testing (rectal and urine nucleic acid amplification test for gonorrhea and chlamydia, rapid plasma reagin for syphilis) conducted at baseline, week 26, and week 52. Logistic regression was used to examine associations between STI incidence and PrEP uptake. Generalized estimating equations were used to evaluate associations between age, PrEP acceptance, sexual behaviors, and incident STIs. RESULTS: Baseline STI prevalence was 14.2%. Men aged <25 years were more likely to have a baseline STI (25.3% vs 6.7%; odds ratio [OR], 4.39; 95% confidence interval [CI:, 1.91, 10.11). Sixty participants (26.5%) acquired ≥1 STI during follow-up; the incidence rate was 34.2 cases per 100 person-years (95% CI, 27.4, 42.9). In adjusted analyses, baseline STI diagnosis (OR, 4.23; 95% CI, 1.82, 9.87; P < .001) and additional C4 time (OR, 1.03; 95% CI, 1.00, 1.06; P = .027) were associated with having an incident STI. STI incidence was not associated with PrEP acceptance or adherence. CONCLUSIONS: While we found higher rates of STIs in younger BMSM, overall rates of STI were lower than in prior PrEP trials, with no increase over time. BMSM with STIs at PrEP initiation may require additional interventions that target STI acquisition risk. CLINICAL TRIALS REGISTRATION: NCT01808352.

A Randomized Controlled Pilot Study of a Culturally-Tailored Counseling Intervention to Increase Uptake of HIV Pre-exposure Prophylaxis Among Young Black Men Who Have Sex with Men in Washington, DC.

Daily emtricitabine/tenofovor is effective at preventing HIV acquisition and is approved for HIV pre-exposure prophylaxis (PrEP). Blacks in the United States have a disproportionately high rate of HIV, and uptake of PrEP has been very low in this population. We conducted a pilot study in a high-prevalence city to test whether a culturally-tailored counseling center for young Black men who have sex with men (BMSM) positively impacted their access and uptake of PrEP. 50 young BMSM were randomized to either a PrEP counseling center group or a control group, and were then encouraged to obtain PrEP from a PrEP provider. At the end of 3 month study, six participants in the intervention group compared with none in the control group had initiated PrEP (p = 0.02). This pilot study demonstrates that a culturally-tailored counseling center might be an effective at increasing the uptake of PrEP in young BMSM.

Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial.

BACKGROUND: Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. CAB is formulated both as an immediate-release oral tablet for daily administration and as a long-acting injectable suspension (long-acting CAB [CAB LA]) for intramuscular (IM) administration, which delivers prolonged plasma exposure to the drug after IM injection. HIV Prevention Trials Network study 077 (HPTN 077) evaluated the safety, tolerability, and pharmacokinetics of CAB LA in HIV-uninfected males and females at 8 sites in Brazil, Malawi, South Africa, and the United States. METHODS AND FINDINGS: HPTN 077 was a double-blind, placebo-controlled phase 2a trial. Healthy individuals age 18-65 years at low HIV risk were randomized (3:1) to receive CAB or placebo (PBO). In the initial oral phase, participants received 1 daily oral tablet (CAB or PBO) for 4 weeks. Those without safety concerns in the oral phase continued and received injections in the injection phase (Cohort 1: 3 injections of CAB LA 800 mg or 0.9% saline as PBO IM every 12 weeks for 3 injection cycles; Cohort 2: CAB LA 600 mg or PBO IM for 5 injection cycles; the first 2 injections in Cohort 2 were separated by 4 weeks, the rest by 8 weeks). The primary analysis included weeks 5 to 41 of study participation, encompassing the injection phase. The cohorts were enrolled sequentially. Primary outcomes were safety and tolerability. Secondary outcomes included pharmacokinetics and events occurring during the oral and injection phases. Between February 9, 2015, and May 27, 2016, the study screened 443 individuals and enrolled 110 participants in Cohort 1 and 89 eligible participants in Cohort 2. Participant population characteristics were as follows: 66% female at birth; median age 31 years; 27% non-Hispanic white, 41% non-Hispanic black, 24% Hispanic/Latino, 3% Asian, and 6% mixed/other; and 6 transgender men and 1 transgender woman. Twenty-two (11%) participants discontinued the oral study product; 6 of these were for clinical or laboratory adverse events (AEs). Of those who received at least 1 CAB LA injection, 80% of Cohort 1 and 92% of Cohort 2 participants completed all injections; injection course completion rates were not different from those in the PBO arm. Injection site reactions (ISRs) were common (92% of Cohort 1 and 88% of Cohort 2 participants who received CAB LA reported any ISR). ISRs were mostly Grade 1 (mild) to Grade 2 (moderate), and 1 ISR event (Cohort 1) led to product discontinuation. Grade 2 or higher ISRs were the only AEs reported more commonly among CAB LA recipients than PBO recipients. Two Grade 3 (severe) ISRs occurred in CAB recipients, 1 in each cohort, but did not lead to product discontinuation in either case. Seven incident sexually transmitted infections were diagnosed in 6 participants. One HIV infection occurred in a participant 48 weeks after last injection of CAB LA: CAB was not detectable in plasma both at the time of first reactive HIV test and at the study visit 12 weeks prior to the first reactive test. Participants in Cohort 2 (unlike Cohort 1) consistently met prespecified pharmacokinetic targets of at least 95% of participants maintaining CAB trough concentrations above PA-IC90, and 80% maintaining trough concentrations above 4× PA-IC90. Study limitations include a modest sample size, a short course of injections, and a low-risk study population. CONCLUSIONS: In this study, CAB LA was well tolerated at the doses and dosing intervals used. ISRs were common, but infrequently led to product discontinuation. CAB LA 600 mg every 8 weeks met pharmacokinetic targets for both male and female study participants. The safety and pharmacokinetic results observed support the further development of CAB LA, and efficacy studies of CAB LA for HIV treatment and prevention are in progress. TRIAL REGISTRATION: ClinicalTrials.gov Registry: ClinicalTrials.gov Trial number: NCT02178800.

A Closer Look at Racism and Heterosexism in Medical Students' Clinical Decision-Making Related to HIV Pre-Exposure Prophylaxis (PrEP): Implications for PrEP Education.

Social biases among healthcare providers could limit PrEP access. In this survey study of 115 US medical students, we examined associations between biases (racism and heterosexism) and PrEP clinical decision-making and explored prior PrEP education as a potential buffer. After viewing a vignette about a PrEP-seeking MSM patient, participants reported anticipated patient behavior (condomless sex, extra-relational sex, and adherence), intention to prescribe PrEP to the patient, biases, and background characteristics. Minimal evidence for racism affecting clinical decision-making emerged. In unadjusted analyses, heterosexism indirectly affected prescribing intention via all anticipated behaviors, tested as parallel mediators. Participants expressing greater heterosexism more strongly anticipated increased risk behavior and adherence problems, which were associated with lower prescribing intention. The indirect effect via condomless sex remained significant adjusting for background characteristics. Prior PrEP education did not buffer any indirect effects. Heterosexism may compromise PrEP provision to MSM and should be addressed in PrEP-related medical education.

Sexual Stereotypes Ascribed to Black Men Who Have Sex with Men: An Intersectional Analysis.

Sexual stereotypes may adversely affect the health of Black men who have sex with men (MSM). Greater understanding of the nature and nuances of these stereotypes is needed. This online, survey-based study used an inductive, intersectional approach to characterize the sexual stereotypes ascribed to Black MSM by the U.S. general public, their distinctiveness from those ascribed to Black men and MSM in general, and their relative prototypicality as compared to dominant subgroups. Members of the public, recruited in 2014-2015, were randomly assigned to survey conditions that varied systematically by race (Black, White, or unspecified) and sexual orientation (gay, heterosexual, or unspecified) of a designated social group. Participants (n = 285) reported stereotypes of their assigned group that they perceived to exist in U.S. culture in an open-response format. Cross-condition comparisons revealed that, overall, Black gay male stereotypes were non-prototypical of Black men or gay men. Rather, stereotypes of Black men were more similar to Black heterosexual men and stereotypes of gay men were more similar to White gay men. Nonetheless, 11 of the 15 most frequently reported Black gay male stereotypes overlapped with stereotypes of Black men (e.g., large penis), gay men (e.g., deviant), or both (e.g., promiscuous). Four stereotypes were unique relative to both Black men and gay men: down low, diseased, loud, and dirty. Findings suggest that Black MSM face multiple derogatory sexual stereotypes, several of which are group-specific. These stereotypes are consistent with cultural (mis)representations of Black MSM and suggest a need for more accurate portrayals of existing sexual diversity within this group.